Business & Finance
Alvotech reports positive top-line results from pharmacokinetic study of Simponi biosimilar
29 November 2023 -

Biotech company Alvotech S.A. (NASDAQ:ALVO) on Wednesday reported positive top-line outcomes from a pharmacokinetic study evaluating AVT05, a biosimilar candidate for Simponi and Simponi Aria (golimumab).

The study, which examined the pharmacokinetics, safety and tolerability of AVT05 in comparison to Simponi in healthy adult subjects, successfully achieved its primary endpoints.

Alvotech initiated a clinical study in May 2023, aiming to compare the efficacy, safety and immunogenicity of AVT05 and Simponi in adults with moderate to severe rheumatoid arthritis.

In the 12 months to October 2023, the combined global revenues from Simponi and Simponi Aria reached nearly USD2.2bn.

Alvotech's current portfolio comprises 11 products and candidates, including one launched product, an approved biosimilar and four biosimilar candidates in clinical studies, including AVT05.

Golimumab is a monoclonal antibody that inhibits tumour necrosis factor (TNF) alpha. Elevated TNF alpha levels have been implicated in several chronic inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.